Sarepta Therapeutics announced today that the U.S. Food and Drug Administration (FDA) is continuing review and internal discussions related to its New Drug Application for eteplirsen and will not complete the work by the goal date of May 26.

Eteplirsen is an exon skipping drug designed to slow the progression of Duchenne muscular dystrophy (DMD) in some kids and adults with the disease.

Sarepta said the FDA has notified the company that it will continue to work past the original decision date to complete its work as quickly as possible. No new decision date has been released.

Be sure to check back at MDA.org for additional information as it becomes available.

Further reading:

https://strongly.mda.org/testimony-from-mda-at-fda-advisory-committee-hearing-for-dmd-drug-eteplirsen/

https://strongly.mda.org/fda-accepts-sarepta-nda-for-eteplirsen-to-treat-dmd/

https://strongly.mda.org/sarepta-reports-data-from-phase-2-trial-of-eteplirsen-for-treatment-of-dmd/